Pharmaceurical Medicine Modules Spring 2014 Barbara Baroutsou MD, PhD, EMAUD Internist ,chair SFEE Medical Directors’ Committee 1

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Spring 2014

• Continuous Professional Education in Pharmaceutical Medicine not existing on Greek University –Medical School and Health Science schools

• SFEE initiative on CPE was welcomed by ACG Graduate School of Arts &Science • Academics, regulators, practitioners, MDs, pharma staff

• The third consecutive year of SFEE –ACG DEREE Continuous Professional education :Modules on Pharmaceutical Medicine • 2012 – 80 students in 3 courses

• 2013 – 130 students in 7 courses

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• SFEE-DEREE CPE organized along 4 main pillars • Scientific, Clinical, Operational and Health Policy

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Spring 2013

• 7 Courses

10 weeks

1. Medical Affairs in Pharmaceutical Medicine

2. Pharmacoepidemiology

3. Introduction to Clinical Research

2 days

4. Applied Biostatistics I

5. Applied Biostatistics II

6. GCP for Investigators

7. Market Access Forum 4

Spring 2013

• 130 students

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15

17

25

16 16

6

35

Students enrolled per course

Series1

Spring 2013

• Excellent attendance (more than 90%)

• Requested MCQ return 100%

• Encouraging feedback on both content and facilities

• 2014 plan considered the insights and ideas

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3.6

3.8 4

4.2 4.4

4.6 4.8

Average assessment per course

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Spring 2014

• INTRODUCTION TO CLINICAL RESEARCH • 10 weeks course- March 20 to June 5 2014

The module will go through the main aspects of clinical research. By the end of the module the attendee should have learned what clinical research is, the rules and regulations under which it is executed, top level insight in 4 therapeutic areas and best practices in the field.

• FROM GENETICS AND TRANSLATIONAL RESEARCH TO PHARMACOGENOMICS AND PERSONALIZED MEDICINE • 10 weeks course– starting March 20 to June 12 2014

This course will provide a comprehensive understanding of key genetic and pharmacologic principles in drug development and use.

The course is scientifically designed & executed in collaboration with the Biomedical Research Foundation of Academy of Athens

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INTRODUCTION TO CLINICAL RESEARCH

Welcome and course overview, why are clinical trials done, what are the key components of a study K. Papageorgiou

Legal and reglatory framework, what was the evolution V. Vazaiou

GCP principles Eri Coroneou

From bench to bedside: How are drugs discovered, tested and approved N. Baibas

Quality Assurance and quality by design, Risk management Fotoula Dragatsi

Pharmacovigilance principles &requirements in clinical tials Maria Polydorou

Neurology Trials S. Papageorgiou

Respiratory Trials Niki Georgatou

Endocrinology trials Konstantinos Fenekos

Oncology Trials George Papaxoinis

Pharmaco-economics Kostas Athanasakis

Statistical Considerations Christina Bamia

Clinical Operations

Fedra Mavroidi

Fedra Mavroidi

CRA Communiction Skills

Deree speaker

Nora Sarikou

Workshop I: Clinical Operations

K. Bouza/K. Papageorgiou

K. Bouza/K. Papageorgiou

Workshop II: Clinical Strategy

J Chondrellis / K Ntzamaras

J Chondrellis / K Ntzamaras

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FROM GENETICS AND TRANSLATIONAL RESEARCH TO PHARMACOGENOMICS AND PERSONALIZED MEDICINE –BRFAA-IIBEAA • March 20 METHODS (DNA analysis, genome organization), applications in pharmacogenomics,

computational genomics DESPOINA SANOUDOU

• March 27 Basic concepts, Ethics, Personalized Medicine KATIA KARALI

• April 3 : Pharmacodynamics and pharmacogenomics ANDREAS PAPAPETROPOULOS • • April 10 : Pharmacogenomics of drug metabolism, transport and efflux. Pharmacogenomics in

drug discovery and development CONSTANTINOS TAMVAKOPOULOS • • May 8 : Infectious and inflammatory diseases (including respiratory) GEORGINA XANTHOU • • May 15: Cancer pharmacogenomics EMA ANASTASIADOU • • May 22: Cardiovascular disease VANGELIS MANOLOPOULOS / DIMITRIS BEIS •

• May 29: Cancer/ Immunometabolism/ obesity KARALIS • • June 5: Nervous system, Behavioral, Addiction ACHILLEAS GRAVANIS/ALEXIA POLLISIDIS • • June 12: Role of pharmacogenomics in the adverse and toxic drug responses, toxicogenetics, drug

receptors, regulatory proteins ANDREAS PAPAPETROPOULOS

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Spring 2014 • GOOD CLINICAL PRACTICE COURSE FOR INVESTIGATORS

• 2-day course 30-31 May 2014 • By academics,regulators ,pharma clinical research experienced staff

• To train new and experienced investigators

• HEALTH OUTCOME RESEARCH AND MARKET ACCESS: • 2 day course 13-14 June 2014

• In affiliation with University of Peloponese Health Policy Dept

An interactive two day session between medical pharmaceutical executives and academics. Presentations of academics will open up to discussions between medical pharmaceutical executives on the topics of market access.

• PROJECT MANAGEMENT IN CLINICAL RESEARCH

• 3 day course 13-14 June & 20 June 2014 • Deree academics & Pharma experienced staff+ Workshop with Lab

• Project Management skills that are applicable to executing a clinical research project. A Phase IV workshop that will practically demonstrate all that was learnt will be included. 11

GCP course for Investigators

• EMA inspector invited

• EOF inspector invited

• NEC members invited

• EOF Head of Clinical trials invited 12

• Historical aspects of GCP

• GCP Responsibilities

• Ethics review and CTA reviews

• Informed Consent

• IMP

• Inspections

• Workshops

HEALTH OUTCOME RESEARCH AND MARKET ACCESS

Welcome &introduction M.Geitona & B.Baroutsou

Improving health care value M. Geitona / Health Economists

Registires and Real world data Panel of Medical Director & Informatics

Health -Patient reported Outcomes studies Panel of Health economists

Comparative effectiveness how is taken into account in reimbursement in Greece and Europe Health Policy Experts

Wrap up od Day 1 M.Geitona & B.Baroutsou

Overview of Day 1 & Introduction to Day 2 M.Geitona &B. Baroutsou

Managing uncertainty in Market Access the way forward Pharma executives

Sustainable health care budgets and pharmaceutical expenditure- Therapeutic protocols &EOPYY Registries

Panel of Health Policy experts &Economists

Reimbursement policy in Greece confusing or promising Pharma executives in Market Access

How can EUNetHTA contribute to minimize EOPYY-payer uncertainty Academic Health Economist

Close out M.Geitona &B. Baroutsou

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PROJECT MANAGEMENT IN CLINICAL RESEARCH

Project Planning and Outline DEREE

Project Management Tools DEREE

Budgeting DEREE

Resource Management DEREE

Risk Management DEREE

Quality Assurance DEREE

Escalation process DEREE

Negotiation Process DEREE

Data Selection DEREE

Data Management DEREE

Vendor Management DEREE

Change Management DEREE

Conflict Resolution DEREE

Leadership and Team Management DEREE

Phase IV workshop: Applying Planning, , Resourcing, Budgeting

Pharma CR staff & DEREE

Phase IV workshop:Risk Management, QA Vendor Selection

Lab

Pharma CR staff & DEREE

Phase IV Workshop: Vendor Management, Resource Management, Problem escalation and solving

Lab

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Spring 2014 • QUALITY MANAGEMENT SYSTEMS OF PHARMACOVIGILANCE

• 2 day course by PV-QA –QP Expert 9-10 May 2014 This module focuses on Quality Management Systems in Pharmacovigilance, including Management of Responsibility, Management of QMS Documentation, Management of Training and Personnel Records, Outsourcing Activities in Pharmacovigilance, Records Management and Quality Control Activities. The course will include case studies & workshops for practical application of knowledge acquired. • RETHINKING MEDICAL AFFAIRS’ ROLE AS BUSINESS PARTNER

AND LEADER - BUILDING NEW STRENGTHS • 2 day course by Deree academics and pharma MDs -executives 20-21

June 2014 A module for employed pharma Medical staff, Medical Directors, Medical Managers, Medical Advisors, Medical Science Liaisons, looking for input for the execution of their daily work. Lecturers will be academics and experienced pharma staff. Topics will cover Medical excellence, strategic vision, leadership skills and business acumen. The course will include case studies &workshops

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QUALITY MANAGEMENT SYSTEMS OF PHARMACOVIGILANCE

Introduction to Quality and QMS in Pharmacovigilance Efi Giannoula

Management Responsibility

Management of QMS Documentation

Management of Training and Personnel Records

Outsourcing Activities in Pharmacovigilance

Records Management

Measuring Pharmacovigilance Quality Management System Performance:Part I: Audits (Internal / External)

Measuring Pharmacovigilance Quality Management System Performance Part II: Inspections

Measuring Pharmacovigilance Quality Management System Performance Part III: A. Key Performance Indicators

Measuring Pharmacovigilance Quality Management System Performance Part III: B. Quality Management Review Meetings

Quality Control Activities in PhV

ISO 9001:2008 and Pharmacovigilance Regulation: A. Basic principles of ISO 9001:2008 requirements B. Performing the GAP Analysis

Unified GxP QMS Implementation: A. The example of a multinational company B. Challenges to face

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RETHINKING MEDICAL AFFAIRS’ ROLE AS BUSINESS PARTNER AND LEADER - BUILDING NEW STRENGTHS

Course Introduction and scope B.Baroutsou

Business leadership and acumen DEREE academics

Breakout session work in teams and report back

case studies

Strategic Vision Panel of Medical Directors

Breakout session work in teams and report back

case studies

Overview of Day 1 and Intro to Day 2 B.Baroutsou

Emotional intelligence and communication skills DEREE academics

Breakout session work in teams and report back

case studies

Scientific and technological leadership Panel Of Medical Directors-

Panel of Medical Directors

Breakout session work in teams and report back

Close out BBaroutsou/ALL 17

SFEE –DEREE CPE Ph Med core members 2014 • Graduate School of Fine Arts &Science

• Dr A.Krepapa, Assistant Dean • V. Kyriakopoulou

• Scientific Advisors (volunteers) • Konstantina Papageorgiou • Efi Giannoula • Katia Karali • M.Geitona • B.Baroutsou

• SFEE Medical Directors Core team • T.Antachopoulou,N.Baibas,C.Kanavos • F.de Lorenzo,N.Papadimitriou,K.Papathoma • Barbara Baroutsou

Reviewed by SFEE Medical Directors Committee Endorsed by SFEE Vice President Y. Vlontzos and SFEE Board of Directors 18

Ag. Paraskevi Campus

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Autumn courses

• New for 2014 ( under design) based on SFEE Medical Directors Committee input

• Non interventional studies

• E medical strategies and tools

• Patient centricity

Note : Open to ideas &collaborations- Please feel free to contact us with your feedback

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OPEN DAY PRESENTATION AGENDA Pharmaceutical Medicine Modules March 4, 2014

• 15:00-15:15 Arrival

• 15:15-15:35 Welcome address - Thimios Zaharopoulos, Ph.D., ACG Provost

• 15:35-16:15 Welcome address – Presentation of Pharmaceutical Medicine Modules, Barbara Baroutsou, Chair of the Medical Director’s Committee of SFEE

• 16:15-17:00 Depiction of clinical research in GREECE. A recent study of the National School of Public Health (ESDY). Announcement of results. Dr K.Athanasakis

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Thank you for your attention Q&As

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